Indaptus Therapeutics to Present New Cohort Data Confirming Original “Pulse-Prime” Hypothesis Via Phase 1 Clinical Trial of Decoy20 at the American Society of Clinical Oncology Annual Meeting
Indaptus Therapeutics (Nasdaq: INDP) unveiled promising new data from their ongoing Phase 1 clinical trial of Decoy20 at the American Society of Clinical Oncology Annual Meeting 2024. The trial involves patients with advanced solid tumors.
The study highlighted Decoy20's pharmacokinetics and immune responses, showing that a single intravenous dose cleared from the bloodstream in 30-120 minutes and prompted the release of over 50 cytokines and chemokines, which are important for immune responses.
Remarkably, Decoy20 maintained a safety profile similar to that of purified lipopolysaccharide (LPS), with adverse effects being generally tolerable and resolving within 90 minutes to 3 days.
Indaptus CMO Roger Waltzman emphasized the significance of these findings and announced that the company would continue with the first multi-dose cohort, with updates expected throughout the year.
- Data supports Decoy20's 'pulse-prime' hypothesis for anti-tumor effects.
- Single dose of Decoy20 cleared from blood within 30-120 minutes.
- Induced transient release of over 50 cytokines and chemokines.
- Safety profile was consistent with that of purified LPS.
- Adverse effects were generally tolerable and short-lived.
- Presentation at a prestigious event like the American Society for Clinical Oncology enhances credibility.
- Continuation of Phase 1 trial indicates ongoing progress.
- Adverse effects, while tolerable, did occur and lasted up to 3 days.
- Data is still preliminary and from Phase 1, indicating that much more validation is needed.
- Current results are based on a single-dose cohort; efficacy in multi-dose regimen is yet to be proven.
Insights
Analysis: The preliminary results for Decoy20, presented at the American Society of Clinical Oncology Annual Meeting, indicate promising initial data from the Phase 1 clinical trial. The rapid clearance of Decoy20 from the bloodstream and the transient induction of over 50 cytokines and chemokines suggest a robust immune activation. This is significant for a few reasons: first, it aligns with the 'pulse-prime' hypothesis of stimulating both innate and adaptive immune responses, essential in cancer treatment. Second, the tolerable safety profile reported could be encouraging for further trials.
For investors, the key takeaway is that these early results provide a foundation for potentially effective and safe cancer therapy. However, it is important to remember that these are early-phase results. Clinical trials can be lengthy and the road to regulatory approval is often challenging. The next steps, including the results from the multi-dose cohort, will be important in determining the viability of Decoy20 as a treatment option.
Analysis: From a financial perspective, the new cohort data and upcoming detailed presentation at a prestigious conference like the American Society of Clinical Oncology are likely to generate positive sentiment around Indaptus Therapeutics. This visibility can be beneficial, potentially leading to an increase in stock price and attracting institutional investors. The Phase 1 trial news could also open doors for partnerships or additional funding, which is critical for clinical-stage biotech companies.
It's worth noting that the biotech sector is inherently risky, with substantial volatility driven by trial results and regulatory decisions. Therefore, while the data presented is promising, it represents one piece of a much larger puzzle. Investors should monitor subsequent phases of the trial and any strategic moves by the company to manage capital and resources effectively.
Poster abstract highlights response across multiple indicators of immune activation with rapid clearance of Decoy20
NEW YORK, May 29, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc, (Nasdaq: INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, today announces data from a poster being presented at the American Society of Clinical Oncology Annual Meeting 2024 on June 1. The conference will be held in Chicago at McCormick Place from May 31-June 4, 2024 where full data will be presented.
In the abstract, titled, “Preliminary results of a Phase 1 study of Decoy20, an intravenous, killed, multiple immune receptor agonist bacterial product in patients with advanced solid tumors,” investigators continued to provide validation from early results of the single dose cohort of its Phase 1 clinical trial. The data presented include the pharmacokinetics and immune response observed in both cohorts in the ongoing Phase 1 trial for Decoy20. A single i.v. dose of Decoy20 disappeared from blood within 30-120 minutes and produced transient induction in plasma of over 50 cytokines and chemokines, many of which have been associated with stimulation of innate and/or adaptive immune responses. These findings are important components of the “pulse-prime” hypothesis for Decoy20’s anti-tumor effect.
The study also showed that despite the presence of multiple immune agonists associated with intact bacteria, the safety profile of Decoy20 was largely as expected for administration of purified lipopolysaccharide (LPS), based on previously published clinical experience. Adverse effects were generally tolerable and resolved with or without treatment within 90 minutes to 3 days.
Roger Waltzman, Indaptus CMO commented, “We continue to receive important validation of the results of our Phase 1 study as they evolve, and presentation at the American Society for Clinical Oncology is an important event for the Company and for our compound. We continue the Phase 1 clinical trial with the first multi-dose cohort and expect to provide updates on progress throughout the year.”
About Indaptus Therapeutics
Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. The Company’s novel approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and pathways and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system-activating signals that can be administered safely intravenously (i.v.). Indaptus’ patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria producing a multiple Toll-like receptor (TLR), Nucleotide oligomerization domain (NOD)-like receptor (NLR) and Stimulator of interferon genes (STING) agonist Decoy platform. The product candidates are designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cells and pathways of innate and adaptive immunity. Decoy product candidates represent an antigen-agnostic technology that have produced single-agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, single agent eradication of established antigen-expressing breast carcinoma, as well as combination-mediated eradication of established hepatocellular carcinomas, pancreatic and non-Hodgkin’s lymphomas in standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts. In pre-clinical studies tumor eradication was observed with Decoy product candidates in combination with anti-PD-1 checkpoint therapy, low-dose chemotherapy, a non-steroidal anti-inflammatory drug, or an approved, targeted antibody. Combination-based tumor eradication in pre-clinical models produced innate and adaptive immunological memory, involved activation of both innate and adaptive immune cells, and was associated with induction of innate and adaptive immune pathways in tumors after only one i.v. dose of Decoy product, with associated “cold” to “hot” tumor inflammation signature transition. IND-enabling, nonclinical toxicology studies demonstrated i.v. administration without sustained induction of hallmark biomarkers of cytokine release syndromes, possibly due to passive targeting to liver, spleen, and tumor, followed by rapid elimination of the product. Indaptus’ Decoy product candidates have also produced significant single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These include statements regarding management’s expectations, beliefs and intentions regarding, among other things: our expectations and plans regarding our Phase 1 clinical trial of Decoy20, including the timing and design thereof; the anticipated effects of our product candidates, including Decoy20; the plans and objectives of management for future operations; our research and development activities and costs; the sufficiency of our cash and cash equivalents to fund our ongoing activities and our cash management strategy; and our assessment of financing options to support our corporate strategy. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to the following: our limited operating history; conditions and events that raise substantial doubt regarding our ability to continue as going concern; the need for, and our ability to raise, additional capital given our lack of current cash flow; our clinical and preclinical development, which involves a lengthy and expensive process with an uncertain outcome; our incurrence of significant research and development expenses and other operating expenses, which may make it difficult for us to attain profitability; our pursuit of a limited number of research programs, product candidates and specific indications and failure to capitalize on product candidates or indications that may be more profitable or have a greater likelihood of success; our ability to obtain and maintain regulatory approval of any product candidate; the market acceptance of our product candidates; our reliance on third parties to conduct our preclinical studies and clinical trials and perform other tasks; our reliance on third parties for the manufacture of our product candidates during clinical development; our ability to successfully commercialize Decoy20 or any future product candidates; our ability to obtain or maintain coverage and adequate reimbursement for our products; the impact of legislation and healthcare reform measures on our ability to obtain marketing approval for and commercialize Decoy20 and any future product candidates; product candidates of our competitors that may be approved faster, marketed more effectively, and better tolerated than our product candidates; our ability to adequately protect our proprietary or licensed technology in the marketplace; the impact of, and costs of complying with healthcare laws and regulations, and our failure to comply with such laws and regulations; information technology system failures, cyberattacks or deficiencies in our cybersecurity; and unfavorable global economic conditions. These and other important factors discussed under the caption “Risk Factors” included in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 filed with the SEC on May 8, 2024, our most recent Annual Report on Form 10-K filed with the SEC on March 13, 2024, and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. All forward-looking statements speak only as of the date of this press release and are expressly qualified in their entirety by the cautionary statements included in this press release. We undertake no obligation to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events, except as required by applicable law.
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